Exercise-Based Strategies for Chronic Back Pain

Official title

Innovative Exercise-Based Strategies for Managing Chronic Back Pain: A Multisystem Health Approach

Overview

This randomized, controlled, five-arm, parallel-group trial will evaluate the effects of 8 weeks of supervised resistance training and developmental position-based exercise, with or without real-time non-invasive intra-abdominal pressure biofeedback, in adults aged 40 to 60 years with chronic low back pain. The trial will compare supervised gym-based agonist-antagonist paired set resistance training with OHMTRACK, supervised gym-based resistance training without OHMTRACK, supervised physiotherapy-based developmental exercise with OHMTRACK, home-based developmental exercise with OHMTRACK, and an active control condition. Primary outcomes will assess changes in pain and physical function after the intervention. Secondary outcomes will include neuromuscular coordination, postural stabilization, cardiovascular, respiratory, metabolic, behavioral, feasibility, and follow-up outcomes.

Detailed description

Chronic low back pain is a prevalent and multifactorial condition associated with impaired physical function, reduced quality of life, and substantial socioeconomic burden. Exercise therapy, especially resistance training, is an important non-pharmacological treatment strategy, but the integration of exercise with real-time monitoring of intra-abdominal pressure remains underexplored. This study will examine whether combining exercise with non-invasive intra-abdominal pressure biofeedback can improve trunk stabilization, movement control, pain, and broader health outcomes.

The trial includes a 2-week familiarization phase, an 8-week intervention phase, and an 8-week post-intervention follow-up without structured exercise. Participants will be randomly assigned in a 1:1:1:1:1 ratio to one of five parallel groups. The supervised gym-based program uses full-body agonist-antagonist paired set resistance training twice weekly for 60 minutes, with three sets of 10 repetitions at 75 percent of one-repetition maximum, 90-second rest intervals, and a 3-0-2-1 tempo. The supervised physiotherapy and home-based arms use developmental position-based exercise emphasizing trunk stabilization, breathing coordination, support, and movement quality. OHMTRACK biofeedback will be used in selected groups to support real-time regulation of intra-abdominal pressure.

Outcome measures will cover pain, trunk muscle function, postural stabilization, body composition, cardiovascular health, respiratory function, metabolic health, strength, functional capacity, adherence, behavioral regulation, and adverse events. Measurements are scheduled at baseline, during the intervention, and through follow-up to examine both immediate and retained effects.

Interventions

• Behavioral Gym settings
  An 8-week supervised full-body resistance training program preceded by a 2-week familiarization phase (4 sessions). During the intervention phase, participants perform training twice weekly for 60 minutes per session. Each session includes a 10-minute warm-up, 40-minute main phase, and 10-minute cool-down. The program consists of 3 sets of 10 repetitions at 75% of 1RM, 90-second rest intervals, and a 3-0-2-1 movement tempo. Training is delivered in a gym setting under professional supervision. R
• Behavioral Physio settings
  An 8-week supervised exercise program based on developmental positions and neurophysiological principles, preceded by a 2-week familiarization phase (4 sessions). Participants exercise twice weekly for 60 minutes per session under physiotherapist supervision. Sessions focus on breathing coordination, deep trunk stabilization, postural control, support function, and movement quality using structured developmental movement sequences.
• Behavioral Home - based settings: exercises based on developmental positions
  An 8-week home-based exercise program based on developmental positions and neurophysiological principles, preceded by a 2-week familiarization phase (4 sessions). Participants perform exercises twice weekly for 60 minutes per session using electronic manuals and video instructions. The program emphasizes breathing coordination, deep trunk stabilization, postural control, and self-correction of movement quality in an unsupervised home setting, with the possibility of contacting the research team
• Behavioral Home - based settings: Usual activity monitoring
  Participants continue their usual daily activities without participating in a structured resistance training or developmental position exercise program. Physical activity is monitored throughout the study using a wearable activity tracker to record daily step counts and overall movement behavior.

Primary outcome measures

• Change in Trunk Flexor and Extensor Muscle Function [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score [Time frame: Baseline to Week 16 (1x every week)]
• Change in DNS-Based Functional Postural Stabilization Performance [Time frame: Baseline, Week 8, Week 12, and Week 16]

Secondary outcome measures (12)

• Maximal Oxygen Uptake (VO2max) During Treadmill Graded Exercise Test [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Quantitative Sensory Testing - Pressure Pain Threshold [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Isometric Mid-Thigh Pull [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Handgrip Strength [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Behavioral Regulation in Exercise Questionnaire (BREQ-3) Subscale Scores [Time frame: Baseline and Week 8]
• Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Throughout the intervention period, Weeks 1-8 (every week)]
• Body Mass Index (BMI) [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Total Body Fat Mass [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Lean mass [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Body Weight [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Serum Total Cholesterol Concentration [Time frame: Baseline, Week 8, Week 12, and Week 16]
• Serum Low-Density Lipoprotein (LDL) Cholesterol Concentration [Time frame: Baseline, Week 8, Week 12, and Week 16]

Eligibility criteria

Inclusion criteria

• Chronic low back pain lasting more than 12 weeks, with current low back pain at screening/baseline.
• Resting blood pressure below 139/89 mmHg.
• Health status allowing participation in moderate-intensity resistance training and aerobic activity.
• Physically active, but not professional athletes.
• Non-smoker.
• Able and willing to provide written informed consent and comply with study procedures

Exclusion criteria

• Absolute or relative contraindications to resistance training or other clinically relevant cardiovascular contraindications.
• Coronary artery disease, heart rhythm disorders, acute myocarditis, Marfan syndrome, or other cardiovascular conditions judged unsafe by the study physician.
• History of myocardial infarction, cerebrovascular disease, peripheral vascular disease, or grade II-IV hypertension.
• Type 1 or type 2 diabetes mellitus.
• Severe obesity (BMI >= 40.0 kg/m2).
• Infectious disease at screening (for example, COVID-19 or influenza).
• Current treatment for chronic low back pain from another healthcare provider.
• Prior spine surgery or lower-limb surgery.
• Structural spinal deformity such as spondylolisthesis or spondylolysis.
• Spinal fracture, inflammatory spinal disorder, or neurological signs of nerve root compromise, including decreased tendon reflexes, sensory loss, or motor deficits.
• Dizziness during exercise.
• Use of medications other than analgesics and non-steroidal anti-inflammatory drugs, unless specifically approved by the study physician.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Czechia · 1 center

• Faculty of Physical Education and Sport, Chrales University — Prague

Identifiers

NCT: NCT07475481 · 095/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗